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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)

Manufactured by Safecare Biotech (Hangzhou) Co. Ltd., China - www.safecare.com.cn 

Device identification number
1490
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), Influenza A, Influenza B
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
1.5 AU (1.5)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.96 % (COVID-19)
False positives
0 % FluB
False positives
0 % FluA
False negatives
0.56 % (COVID-19)
False negatives
0 % FluB
False negatives
0.56 % (FluA)
Precision
Evaluated
Accuracy
100 % (FluB)
Accuracy
99.54 % (FluA)
Accuracy
98.41 % (COVID-19:)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (FluA)
Clinical Sensitivity
100 % (FluB)
Clinical Sensitivity
97.04 % (COVID-19)
Type of antigen
nucleoprotein
Notes
FP: FluA:0, FluB:0. FN: FluA:0.56%, FluB: 0. Accuracy: FluA:99.54%, FluB:100%. Clinical Sensitivity: FluA:100%, FluB:100%.

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements